the Effect of Diane-35 Pretreatment on In-vitro Fertilization Outcome for Patients With Polycystic Ovary Syndrome

The Effect of Diane-35 Pretreatment on Endocrine and Clinical Profile for Patients With Polycystic Ovary Syndrome Undergoing In-vitro Fertilization

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01752270

Enrollment

100

Registered

2012-12-19

Start date

2012-12-31

Completion date

2014-12-31

Last updated

2012-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Brief summary

Polycystic Ovary Syndrome is the most common endocrine disorder in women, is estimated to affect more than 5% of the population and is associated with chronically elevated serum androgen concentrations.Evidence suggests that polycystic ovary syndrome has a negative impact on pregnancy outcomes, with an increased risk of gestational diabetes, hypertensive disease during pregnancy,and preterm birth,which is partially related with the hyperandrogenic environment.Diane-35 has been proved to be the most effective anti-androgenic drug.At present, there is no direct evidence that Diane-35 has a positive effect on the clinical outcome of polycystic ovary syndrome patients undergoing In-vitro fertilization/Intracytoplasmic sperm injection.

Interventions

DRUGDiane-35 pretreatment

Diane-35 is applied from the third day of menstrual cycle for 21 days with a 7-day interval, for 3 consecutive cycles.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

Healthy volunteers

Inclusion criteria

* diagnosed polycystic ovary syndrome patients according to Rotterdam criteria * with hyperandrogenism and/or clinical hyperandrogenic manifestations * no other oral contraceptives treatment for at least 3 months before this experiment * no any other assisted reproductive therapy * accompanied with fallopian tube and/or male factors * normal hepato-/nephro- function

Exclusion criteria

* oral contraceptive pills contraindications, eg.Deep Venous Thrombosis * smoking, drunk * exclude other infertile factors, eg.endometriosis, abnormal thyroid function, etc.

Design outcomes

Primary

Measure	Time frame
fertilization rate	up to 2years

Secondary

Measure	Time frame
implantation rate	up to 2years

Other

Measure	Time frame
clinical pregnancy rate	up to 2years

Countries

China

Contacts

Primary ContactXiaokun Hu

eoshappy@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026